Bladder Care Following Laparoscopy for Benign Non-Hysterectomy Gynaecological Conditions – A Randomised Controlled Trial

INTERVENTION: It is standard surgical practice to place an indwelling catheter during laparoscopy for gynaecological surgery to increase visualisation of the pelvic organs and to minimise the risk of intraoperative bladder injuries, in particular at the placement of the suprapubic laparoscopic port. It is the practice of some surgeons to leave the urinary catheter in situ post‐operatively, whilst others remove the catheter immediately post‐operatively. The primary objective of this clinical investigation is to determine whether immediate removal of the urinary catheter after laparoscopic surgery for benign non‐hysterectomy gynaecological conditions (excluding surgery for prolapse and urinary incontinence) will affect the rate of post‐operative complications involving the urinary tract. Patients in the immediate catheter removal group will have the urinary catheter removed in the operating theatre at the completion of surgery. With regards to bladder function, the patient is considered fit for discharge when she is able to void >=150 ml on two successive occasions. Other factors may prevent discharge and these will be documented. This reflects the current standard practice at many institutions after laparoscopy for benign gynaecological conditions (except prolapse and incontinence). In addition to the above standard practice, study subjects allocated to this group will also have their PVR measured by bladder scan (in accordance to the parameters outlined above). Medical staff and the study subjects will be blinded from the results of the bladder scan. Accordingly, the decision for timing of hospital discharge is not influenced by the results of the bladder scan. This reflects the current standard practice at many institutions where bladder scans are not routinely performed after laparoscopy for benign gynaecological conditions. Bladder scans may be performed when there is a clinical indication to measure the PVR (for example, when the subject is unable to void >=150 ml on two successive occasions). The results of these bladder scans, and how they influence the management and timing of hospital discharge, will be documented. CONDITION: Post‐operative bladder care following laparoscopy for benign non‐hysterectomy gynaecological conditions PRIMARY OUTCOME: Incidence and pattern of post‐operative voiding dysfunction: ; At the 6 week postoperative clinic review, study subjects will complete two validated questionnaires regarding lower urinary tract symptoms (ICIQ‐FLUTS and ICIQ‐LUTSqol). Incidence of post‐operative urinary tract infection: ; At the phone interview 10‐14 days postoperatively, and at the 6 week postoperative clinic review, study subjects will be asked whether they have been diagnosed with a urinary tract infection, and whether they have had any unscheduled presentation to a general practitioner, emergency department, or outpatient service (clinic/rooms). SECONDARY OUTCOME: Duration of hospital stay: ; This will be calculated from the date and time of hospital admission and hospital discharge documented on the case report form and hospital medical records. Economic analyses of the two modalities for care Post‐void residual urine volume (PVR) in patients before surgery, and to commence the development of a nomogram for the female population: ; Upon admission to hospital for surgery, study subjects will: ; ‐ Complete the ICIQ‐FLUTS questionnaire. ; ‐ Undergo independent (no catheter) uroflowmetry in a private room. ; ‐ Have a transabdominal bladder scan to measure the PVR ; ‐ Undergo a urinary pregnancy test; ; ‐ Provide a mid‐stream urine (MSU) sample for urinalysis. Readmission to hospital (incidence and indication): INCLUSION CRITERIA: ‐ Elective laparoscopy for a benign gynaecological condition ; At the phone interview 10‐14 days postoperatively, and at the 6 week postoperative clinic review, study subjects will be asked whether they have had any unscheduled presentation to a general practitioner, emergency department, or outpatient service (clinic/rooms). Permission will be sought to obtain further information from other health practitioners regarding these presentations/hospital admissions. Unscheduled presentation to General practitioner, Emergency department, Outpatient service (clinic/rooms): ; At the phone interview 10‐14 days postoperatively, and at the 6 week postoperative clinic review, study subjects will be asked whether they have been diagnosed with a urinary tract infection, and whether they have had any unscheduled presentation to a general practitioner, emergency department, or outpatient service (clinic/rooms). ‐ Patients to be aged >=18 years at time of surgery ‐ Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow‐up ‐ Patients who are capable of, and have given written informed consent to their participation in the study. ‐ Patients presenting with benign gynaecological conditions that require surgical intervention as agreed to by the patient and her attending medical team.